Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

Hypokalemia Clinical Trial

Official title:

Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605202
• Other study ID #: Lakritsi ja hypokalemia
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2008
• Last updated: December 10, 2009
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: December 2009
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This clinical trial is designed to study the effect of the combination of licorice and hydrochlorothiazide on plasma potassium levels in volunteers. In one arm, 10 healthy volunteers will be given 32 grams of licorice a day together with a 25 mg dose of daily hydrochlorothiazide for 14 days. This combination is compared with 32 grams of licorice a day for 14 days given in the other arm. The study is a randomized, open-label cross-over trial. There is at least a 3-week wash-out between the arms. The hypothesis is that the combination of licorice and hydrochlorothiazide will cause hypokalemia. The main outcome measure is the change in the plasma level of potassium between the arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy volunteer

• Age 18-40 years

Exclusion Criteria:

• Any continuous medication

• Any significant disease

• Hypotension or hypertension

• Allergy to licorice or hydrochlorothiazide

• Pregnancy and breast feeding

• Fear of needles and previous difficult blood samplings

• Substance abuse

• Participation in another clinical drug trial within 1 month of enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypokalemia

Intervention

Drug:
• Hydrochlorothiazide
Hydrochlorothiazide 25 mg a day for 14 days.

Dietary Supplement:
• Licorice
Licorice candy 32 grams a day for 14 days.

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Hukkanen J, Ukkola O, Savolainen MJ. Effects of low-dose liquorice alone or in combination with hydrochlorothiazide on the plasma potassium in healthy volunteers. Blood Press. 2009;18(4):192-5. doi: 10.1080/08037050903072515. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Potassium		Baseline and 2 weeks	Yes